St. Jude Medical (St. Paul, Minnesota) continues to expand and refine its portfolio of neurostimulation offerings with FDA approval of the Penta surgical lead, the first five-column lead on the U.S. market using the smallest available electrodes.
Unveiled at the annual North American Neuromodulation Society (Glenview, Illinois) meeting in Las Vegas, "The Penta lead is designed to increase targeting of the lead so that physicians can more specifically address multifocal pain," Tom Hickman, VP of Product Management for St. Jude Neuromodulation, told Medical Device Daily. "The lead itself is probably best used for our patients with failed back surgery syndrome. That's the largest patient population that we have in the chronic pain niche. Those patients have low back and leg pain, which is multifocal pain. There are different fibers running to address leg pain and back pain. This lead enables physicians to optimize stimulation in very specific areas and create small programs that run together to create a very specific stimulation pattern for each patient."
Failed back surgery syndrome is reported to affect nearly 30% of all people who have spinal surgery. Treatment options are limited. Short of having another surgery, neurostimulation has offered at least a 50% reduction in pain and 47% of treated patients report satisfaction with the therapy, according to research by St. Jude. Hickman said the company has no specific data ready to disclose on the effectiveness of the Penta.
St. Jude already has five neurostimulation leads on the market. The Penta is not a replacement, but an enhancement specifically for use in multifocal pain. This lead provides the broadest lateral electrode span of any neurostimulation lead on the market with a paddle configuration of 10.9 mm wide. The smaller size is enabled by a micro-texturing process which allows for greater amounts of current to be delivered via the small electrodes. The result is a lead that can more specifically focus current over a greater lateral area of the spinal cord, which may provide better coverage for managing hard to control chronic pain.
"Neurofibers running up through spinal cord lay out in a lateral fashion," Hickman said. "The ability to provide more columns of electrodes placed at an optimum distance allows for the physical capability to specifically target pain fibers and create pain release in a specific and focused manner."
The leads aren't just smaller; new technology is incorporated.
"The electrodes are gated by the amount of charge density they can provide to the body," he said. "The propriety micro-texturing enables high-charged density with small electrodes. We couldn't have created a five-column lead without smaller electrodes. And those smaller electrodes weren't possible without the surface optimization with micro-texturing."
Micro-texturing enables the surface area of electrodes to be greater. That greater surface area allows charge to be more concentrated.
To treat the pain of failed back surgery, a lead – basically a small insulated wire with multiple electrodes – is placed in the epidural space near the spine. Mild electrical pulses are carried from the neurostimulator to the lead's electrodes to interrupt or mask the transmission of pain signals to the brain. The whole system can be customized to meet each patient's needs.
The neurostimulator is enabled by another new product release from St. Jude: MultiSteering Technology software for Rapid Programmer is a programming platform used to optimize neurostimulation therapy. The software is designed to help healthcare professionals program devices for patients with complex pain patterns to manage chronic pain of the trunk and limbs, and pain from back surgeries that have failed. The software:
• Allows more than 10 times the number of electrode configurations to be evaluated in the same amount of time as conventional programming.
• Captures multiple painful areas by enabling the clinician to evaluate stimulation patterns in real time.
• Provides control of multiple stimulation fields for optimal pain coverage.
"The amount of stimulation is provided on a patient-by-patient basis," Hickman said. "They are given an external device that controls how it's provided. Physicians optimize the program and then give a prescribed program to patient with a handheld device."
St. Jude reports that more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.
Lynn Yoffee; 770-361-4789